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FDA Accepts New Drug Application for Vatiquinone to Treat Friedreich Ataxia
FDA Accepts New Drug Application for Vatiquinone to Treat Friedreich Ataxia

February 19th 2025

The FDA also granted priority review, with a Prescription Drug User Fee Act target action date of August 19, 2025.

This marks the first approval for the only non-invasive disease-modifying treatment for SMA. | Image Credit: Aquir | stock.adobe.com
FDA Approves Risdiplam Tablet for Spinal Muscular Atrophy

February 12th 2025

The designation is based on the AMULET (NCT03611569) phase 2 trial, which was the first-in-human study of the drug. | Image Credit: monticellllo | stock.adobe.com
FDA Grants Fast Track Designation to Amlenetug As Treatment for Multiple System Atrophy

February 12th 2025

FDA Grants Fast Track Designation to Troculeucel for Moderate Alzheimer Disease
FDA Grants Fast Track Designation to Troculeucel for Moderate Alzheimer Disease

February 12th 2025

The approval is based on results from the phase 3 TOLEDO (NCT02006121) study. | Image Credit: airdone | stock.adobe.com
FDA Approves Apomorphine for Treatment of Motor Fluctuations in Parkinson Disease

February 4th 2025

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